Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma
- To evaluate the efficacy of Zevalin for the treatment of low-grade follicular Non-Hodgkin's lymphoma of the orbit or MALT of conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy and external examination of the conjunctiva), and external photography whenever possible.
- To establish the safety profile in this patient population using clinical examination including slit lamp biomicroscopy, and evaluation of the tear film with Schirmer's test.
- To establish the dosimetry for Zevalin in the orbit in the first 3 patients who agree to undergo dosimetry.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Trial of Radioimmunotherapy With Yttrium 90-Labeled (90Y) Zevalin for Low-Grade Follicular Non-Hodgkin's Lymphoma or MALT of the Orbit/Conjunctiva|
- Number of Patients with CR or PR Response [ Time Frame: 3 months ] [ Designated as safety issue: No ]Tumor response to therapy based on clinical parameters and radiographically. At 3 months, tumor response classified as CR (complete response) or PR (partial response), or SD (stable disease), or PD (progressive disease).
|Study Start Date:||February 2004|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Zevalin + Rituximab
Rituximab 250 mg/m^2 IV over 4-6 hours x 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes x 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts x 1 week.
250 mg/m^2 IV over 4-6 hours x 2 weeks.
Other Name: RituxanDrug: Zevalin
5 mCi/kg IV over 30 minutes x 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts x 1 week.
Rituximab and Zevalin are monoclonal antibodies that bind to lymphoma cells and cause cell death.
As is the case for all patients with orbital lymphoma, an orbital biopsy must be performed to confirm the diagnosis and status of the orbital lymphoma. The study doctors must first make sure that the disease has not spread too much and is not severe enough to require immediate treatment with chemotherapy before you can begin treatment on this study. You will have about 4 teaspoons of blood drawn. Women who are able to have children must have a negative blood or urine pregnancy test.
You will receive two injections of rituximab by vein over about 4 to 6 hours. This is followed by an infusion of Zevalin over about 30 minutes on the same day. Whole body images will be performed immediately and at 4-6, 24, 72, and 144 hours after receiving Zevalin. About 1 week later, you will receive a second infusion of rituximab and Zevalin.
You may be taken off the study if your orbital lymphoma does not respond within three months of receiving rituximab and Zevalin. Researchers will measure your response to therapy using MRI of the orbit and an evaluation of the eye in the clinic. If you are taken off study, you will be given the option of receiving external beam radiation therapy as treatment for the disease.
Follow-up evaluations will be done every 3 months for 2 years and every 6 months for Years 3 and 4. This testing is considered standard of care and would include medical history, physical exam, blood tests, and urine tests. The status of the disease will be evaluated using CT scan or MRI of the orbit every 3 months for the first year and every 6 months for Years 2, 3, and 4. Blood tests (about 4 teaspoons each) will be every 3 months for the first year and may be continues every 3 to 6 month until they become negative or you start another anti-cancer therapy.
This is an investigational study. Zevalin and rituximab are both FDA approved but their use together in this study is investigational. A total of up to 12 patients will take part in this study. All will be enrolled at M.D. Anderson.
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bita Esmaeli, MD||M.D. Anderson Cancer Center|